The Effect of Ophiocephalus Striatus Extract on Levels of IGF-1, Albumin, and MNA Score in Elderly With Malnutrition

Malnutrition Clinical Trial

Official title:

The Effect of Ophicephalus Striatus Extract on Levels of Insulin-like Growth Factor-1 (IGF-1), Albumin, and Mini Nutritional Assessment Score in Elderly Patients With Malnutrition: A Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065595
• Other study ID #: 16268
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2017
• Last updated: February 22, 2017
• Start date: October 5, 2016
• Est. completion date: February 14, 2017

Study information

• Verified date: February 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind randomized controlled trial comparing the effect of Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes are the level of IGF-1, albumin, and MNA score.

Description:

This research was conducted in Cipto Mangunkusumo General Hospital and M. Djamil General Hospital, in collaboration with Biomedical Laboratory Faculty of Medicine University of Andalas and Prodia Laboratory, Indonesia. The inclusion criteria were elderly patients (≥ 60 y.o.) with malnutrition (MNA score ≤ 23,5) and hypoalbuminaemia (< 3,5 g/dL), had been treated, and permitted to leave from the hospital. All participants had been interviewed and physically examined to measure the anthropometric profile. Investigators also measured participant's Activity of Daily Living ADL Barthel, Geriatric Depression Scale (GDS), and Abbreviated Mental Test (AMT) to assess participant's compliance for consuming Ophiocephalus striatus extract. Blood samples were obtained to measure participant's level of IGF-1 and albumin before intervention.

Recruited-randomized participants were classified into two groups (control and intervention) with double-blind scheme. Intervention group was given the extract 5 grams two times/day for two weeks. After two weeks, all participants were invited back to out-patient clinic in hospital. MNA score was measured after the intervention. Blood sample were obtained again to know if there were any changes in IGF-1 level and albumin level.

Finally, investigators analyzed results to generate the conclusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 14, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elderly patient (= 60 y.o.)

• Malnutrition or high risk for malnutrition (MNA score = 23,5)

• Hypoalbunemia (albumin level < 3,5 g/dL)

Exclusion Criteria:

• chronic liver disease (liver cirrhosis) or severe liver dysfunction or increasing ALT > 3x normal

• renal dysfunction with glomerulus filtration rate (< 30mL/minute)

• nephrotic syndrome

• acute infection / stroke / trauma

• neoplasma

• depression with Geriatric Depression Scale > 10

• hypersensitivity to Ophiocephalus striatus

• receive parenteral albumin

• refuse to accept the treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Ophiochepalus striatus extract
each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day

Other:
• Placebo
each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IGF-1	IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)	2 weeks
Primary	Serum albumin	Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)	2 weeks
Primary	MNA score	MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.	2 weeks